Regulatory Manager / Senior Regulatory Manager
Core
Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures in the life sciences industry.
Role type
Senior IC Regulatory Manager
Builds
Regulatory submissions (CTA/IND, annual reports, marketing applications) and strategic regulatory input for oncology and rare disease therapies.
Domain
Life Sciences / Clinical Trials / Regulatory Affairs
Required skills
Regulatory strategy, Clinical submission leadership, CRO or Pharma experience, Drug development lifecycle knowledge, Regional regulatory expertise (EU/US), ICH GCP guidance, Project management, Team leadership
Preferred skills
None explicitly stated
Technologies
None explicitly stated
Responsibilities
Compile and review applications to Regulatory Authorities; Develop and review documents for submission; Serve as representative of Global Regulatory Affairs at project and business development meetings; Oversee and coordinate Regulatory Affairs Specialists; Maintain project plans and regulatory intelligence tools; Provide ICH GCP guidance and training; Assist in establishing company standards for submitted information.
Seniority
Senior, hands-on IC